MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTIC SUN DEVICE

Model Number 50000000

Device Problem Insufficient Heating (1287)

Patient Problems Seizures (2063); No Code Available (3191); Convulsion/Seizure (4406)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the infant patient was still not at target temperature on the arctic sun device. Patient should have completed rewarm 2 hours ago but neonatal arctic gel pads were in use. The patient temperature was 35c, the target temperature was 36. 5c and the water temperature was 40c. Trend indicator was in thermoneutral. Concerned and wants to ensure the arctic sun device was working properly. The user has not had an infant unable to rewarm before. Discussed medications being given to patient was keppra, fentanyl, dopamine and versed drip. The user usually does not order versed drip, but it has been the medication able to control patient seizures. Discussed medication affects on rewarming. Discussed counter warming with radiant warmer set to target temperature and watching patient to ensure overshoot does not occur. Also noted blankets could be used to assist with counter warming. Going to try radiant warmer and would call back with any additional questions. Per follow up via nurse on (b)(6) 2020, the nurse had added a radiant warmer and increased the room temperature. The nurse denied a administering versed and was unsure which arctics sun device the infant had been on as patient was completed last week and the arctic sun device has since been moved around. No further issues. The arctic sun device was still in service.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 10741457
• MDR Text Key: 213236629
• Report Number: 1018233-2020-20463
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional,other,use

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000
• Device Catalogue Number: 50000000-BARD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/27/2020 Patient Sequence Number: 1